Clinical trial · Interventional
A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer
A Phase Ib/2 Clinical Study to Evaluate the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of Fruquintinib Combined With Paclitaxel in Patients With Advanced Gastric Cancer
NCT02415023CI-TRIAL-00043434completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fruquintinib+paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fruquintinib+paclitaxel
- description
- fruquintinib combined with paclitaxel. Fruquintinib treatment: administration for 3 weeks followed by 1-week break, and administration every day for the first 21 days.Paclitaxel is administered once weekly in the first three weeks of each cycle.
- interventionNames
- Drug: fruquintinib+paclitaxel
Primary outcomes (3)
- measure
- incidence of DLT
- timeFrame
- every subject's DLT observation window is 4 weeks
- measure
- progression free survival of RP2D
- timeFrame
- from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year
- description
- using RECIST v1.1 progressive disease (PD), using RECIST v 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Patients with local advanced and/or metastatic gastric cancer confirmed by histology and/or cytology; 3. Fail in previous first-line standard chemotherapy 4. Aged 18-70years (inclusive); 5. Body weight ≥40 kg; 6. At least one measurable lesion (according to RECIST1.1); 7. Physical status score (ECOG score) 0-1; 8. Expected survival \>12 weeks. Exclusion Criteria: 1. Who are participating in another drug clinical trial in the past 4 weeks; or receive systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 4 weeks prior to administration of the study drug; 2. Who previously received VEGF/VEGFR inhibitors; 3. Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE\>grade 1), or not completely recovered from previous surgery; 4. Active brain metastasis(with clinical symptom); 5. Other malignancies except squamous-cell or basal cell carcinoma, and cervical carcinoma in situ in the past 5 years; 6. Uncontrolled clinical active infection, e.g. acute pneumonia, hepatitis B or active hepatitis C; 7. Dysphagia, intractable vomiting or known drug malabsorption;
References
Publications (1)
- RESULT1. The 16th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) 2013 2. Elkerm YM, Elesaid A, AL-Batran, et al. Final results of a phase II trial of docetaxel-carboplatin- FU in locally advanced gastric carcinoma[abstract]. Presented at the 2008 gastrointestinal cancers symposium 2008.